The Vivos DNA Appliance is now FDA Approved for the treatment of mild-moderate obstructive sleep apnea. It is considered a medical device because it is used to treat a medical condition, so it is subject to regulation. Medical device regulators like the U.S. Food and Drug Administration are tasked with protecting consumers by ensuring the safety and effectiveness of medical devices on the market. Under normal circumstances, it would be reasonable for a consumer to assume that having FDA approval for a medical device means that the device is safe and effective. Given that my treatment with the ..read more

If you’ve been following my health journey for any length of time, you’ll have noticed that I’ve tried a lot of things to recover my energy and vitality. Being diagnosed with severe obstructive sleep apnea was a major turning point for me, but it was also the start of a new quest to find an effective treatment for the condition that would work for me. There are so many options to consider, and even going with the default recommendation of my sleep specialist to just use CPAP didn’t turn out to be trivial. I fell through the cracks for being diagnosed with obstructive sleep apnea for years simp ..read more

Yesterday I received a response from the Therapeutic Goods Administration’s Device Support Team in response to my Medical Device Incident Report regarding the failure of my Vivos mRNA Appliance and the fact that it tipped my teeth. The TGA’s response states that: “The TGA is aware of this type of adverse event and is monitoring the situation.” “Reports not investigated are used for monitoring and trending analysis.” “In this instance, no further investigation of the reported event will occur.” The only information about the event in the response is a redacted version of the information I sup ..read more

I’ve decided to stop using my Vivos mRNA Appliance after a sleep study showed that it has had no effect on my severe obstructive sleep apnea after 20.5 months of use. I had the sleep study in June specifically to see what permanent impact the appliance has had on my airway during sleep. The polysomnograph was conducted untreated with neither Vivos mRNA Appliance nor CPAP in use so I could compare against my previous untreated sleep study. The results were disappointing, to say the least. Here is a summary table comparing the results of the sleep studies before treatment on 27th June 2019 and a ..read more

No news is no news. This update brings us to the end of May 2022. Look forward to more excitement next month… Here are this month’s graphs: Twenty Months Vivos mRNA Appliance Usage Twentieth Month Vivos mRNA Appliance CPAP Pressure Trend Twentieth Month Vivos mRNA Appliance CPAP Pressure TrendTwenty Months Vivos mRNA Appliance CPAP Pressure Trend Twenty Months Vivos mRNA Appliance CPAP Pressure TrendTwentieth Month Vivos mRNA Appliance AHI and Event Trend Twentieth Month Vivos mRNA Appliance AHI and Event TrendTwenty Months Vivos mRNA Appliance AHI and Event Trend Twenty Months Vivos mRNA Appl ..read more

I appear to have a cold, and you appear to be getting an update. This brings us to the end of April 2022. Here are this month’s graphs: Nineteen Months Vivos mRNA Appliance Usage Nineteen Months Vivos mRNA Appliance UsageNineteenth Month Vivos mRNA CPAP Pressure Trend Nineteenth Month Vivos mRNA CPAP Pressure TrendNineteen Months Vivos mRNA CPAP Pressure Trend Nineteen Months Vivos mRNA CPAP Pressure TrendNineteenth Month Vivos mRNA AHI and Event Trend Nineteenth Month Vivos mRNA AHI and Event TrendNineteen Months Vivos mRNA AHI and Event Trend Nineteen Months Vivos mRNA AHI and Event Trend Ni ..read more

I apologise for the delay in this update; I’m almost 4 months behind as I’ve been focusing on other things. Here is the update for March 2022. I reviewed the airway intelligence report from my latest CBCT and intraoral scan with my provider and concluded that I should keep wearing the appliance and face mask without expanding it any further. Here are this month’s graphs: Eighteen Months Appliance Usage Eighteen Monts Vivos mRNA Appliance UsageEighteenth Month CPAP Pressure Trend Eighteenth Month Vivos mRNA CPAP Pressure TrendEighteen Months CPAP Pressure Trend Eighteen Months Vivos mRNA Applia ..read more

This month I’ve been focussed on recovering from nasal surgery, wearing my myofunctional therapy spots, grieving my mum’s death, going back to Uni, optimising my sleep hygiene, and having a life. I’m still waiting to hear back from Vivos via my provider with their analysis of my mid-treatment CBCT scans taken back in November. Appliance wear isn’t my top priority until I hear from them whether it’s likely to tip my teeth any further. I still sleep with it, but my usage has dropped down to an average of about 12 hours a day this month. I haven’t tried sleeping with the facemask this month since ..read more

I finally got around to reading Breath: The New Science of a Lost Art by James Nestor. It’s an interesting book and worth a read for anyone with a breathing disorder or unexplained chronic health issues. The book tells the story of Nestor’s journey through the world of breathing health, starting out with his own childhood health issues developed as a result of being a chronic mouth breather. He does an experiment where he plugs his nose forcing him to mouth breathe, and notices a decline in his health, including development of sleep apnea which disappeared after he started nasal breathing agai ..read more

Another update for graph lovers. This brings us back up to date with data up to the end of January 2022. I didn’t use CPAP for an extra week after nasal surgery due to the bleeding incident, so the data starts again on 11th January 2022. I only wore the appliance about 11 hours per day while my nose was recovering and didn’t wear the facemask at all because it’s not particularly comfortable. I’m now wearing the facemask during the day again but haven’t been sleeping particularly well, possibly because I’ve been grieving my parent’s deaths, so I haven’t tried sleeping with it at night again. Si ..read more